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HaiPhai.AI Fluency for Biotech
Curriculum · Role Path: Regulatory Affairs

Capstone — Your Regulatory Affairs AI Playbook

Lesson 5~14 min

Module 04G · Lesson 05

Capstone — Your Regulatory Affairs AI Playbook

Reading time: 14 minutes (plus 90-minute workshop) Track: Role Path — Regulatory Affairs · Capstone Prerequisites: Module 04G · Lessons 01-04

What this lesson does

The capstone for regulatory affairs. Same structure as previous capstones, customized for the highest-compliance role path in this curriculum.

You'll produce:

  1. A prompt library — 12-15 prompts for regulatory work
  2. A workflow map for your top recurring projects
  3. A verification checklist tuned to regulatory standards
  4. A 30-day plan

01 · Part One — Prompt library

The prompts to start with:

Intelligence prompts

Prompt 1 — Guidance document summarization (from Lesson 04)

Prompt 2 — Advisory committee analysis (from Lesson 04)

Prompt 3 — Approval pattern comparison (from Lesson 04)

Prompt 4 — Cross-region comparative analysis (from Lesson 04)

Submission prompts

Prompt 5 — Submission section drafting (from Lesson 02)

Prompt 6 — Cross-section consistency check (from Lesson 02)

Prompt 7 — Response to agency questions

Senior regulatory strategist drafting response to FDA query. Query: [exact text]. Our position: [your view]. Supporting information: [data and references].

Draft response that:
1. Directly addresses what was asked
2. Provides specific supporting evidence
3. Uses regulatory-appropriate language
4. Notes any clarifying questions we have back
5. References relevant prior submissions or interactions

Format: per our standard. Length: appropriate to query depth.

Meeting prep prompts

Prompt 8 — Strategic framing (from Lesson 03)

Prompt 9 — Question anticipation (multi-reviewer) (from Lesson 03)

Prompt 10 — Mock Q&A development (from Lesson 03)

Prompt 11 — Challenger workflow (from Lesson 03)

Internal prompts

Prompt 12 — Internal regulatory memo

Senior regulatory strategist drafting internal memo. Audience: [program leadership / executive team / specific function]. Topic: [issue].

Required elements:
1. Bottom line at top (one sentence: what we recommend / what we're flagging)
2. Background (1-2 paragraphs)
3. Analysis (the substance)
4. Recommendation with reasoning
5. Risks and how to address
6. Specific decisions needed

Length: [target]. Tone: factual, confident where supported, honest about uncertainty.

Prompt 13 — Cross-functional translation

Senior regulatory strategist translating regulatory consideration for [audience: clinical / commercial / executive].

Topic: [regulatory issue]
Their decision context: [what they're trying to decide or do]

Translate into:
- Plain language (no regulatory jargon without immediate translation)
- Decision-relevant framing (what this means for their work)
- Specific actions they should take
- What they should escalate to regulatory

Length: 1 page.

Pre-submission planning

Prompt 14 — Pre-submission gap analysis

Senior regulatory strategist conducting gap analysis for [planned submission type]. Per current FDA guidance / template, identify:

1. Required content elements
2. Our current state for each element (have / partially have / don't have)
3. Gaps that require new work
4. Risks for each gap (timeline, quality, regulatory)
5. Recommendations for closing gaps

Source: [guidance document + our current draft materials]

Prompt 15 — Submission roadmap

Senior regulatory strategist building submission roadmap for [program]. Target: [submission type] in [timeframe].

Build:
1. Sequence of required activities
2. Dependencies between activities
3. Critical path
4. Risk points
5. Resource requirements (functions involved)
6. Decision points along the way

02 · Part Two — Workflow maps

Recommended workflows to build:

  • New submission section — from spec through final filing
  • Agency meeting preparation — from strategy through post-meeting documentation
  • Response to deficiency letter — from receipt through filed response
  • Quarterly regulatory intelligence routine — from scan through team brief
  • New guidance impact assessment — from publication through strategy update

Map each: trigger, steps, verification gates, variants.

03 · Part Three — Verification checklist

## Pre-finalization checklist (regulatory affairs)

### Factual accuracy
- [ ] Every cited regulation, guidance, or precedent verified current
- [ ] Every cross-reference to other submission documents verified
- [ ] Every quantitative claim traced to source
- [ ] Every prior interaction reference matches actual record

### Currency
- [ ] Guidance versions current (especially if AI used)
- [ ] Recent agency positions reflected
- [ ] Recent precedents considered

### Policy compliance
- [ ] AI use consistent with organizational policy
- [ ] Documentation requirements met
- [ ] Disclosure requirements (if any) addressed
- [ ] Appropriate environment used (zero-retention for Tier 4)

### Submission standards
- [ ] All required elements present per guidance
- [ ] Format compliance (CTD module structure, etc.)
- [ ] Cross-references resolved
- [ ] Terminology consistent
- [ ] No claims exceeding data support
- [ ] No promotional language

### Documentation
- [ ] AI use logged (tool, model, date, sections, sources, verification, reviewer)
- [ ] Working document maintained
- [ ] Senior review per SOP
- [ ] Filed in appropriate location

04 · Part Four — 30-day plan

Week 1 — Library building

Build prompts. Customize for your specific therapeutic area, document types, and organization's templates.

Week 2 — Workflow mapping

Build workflow maps. Use on real projects.

Week 3 — Verification habituation

Apply checklist mechanically. Note what's caught.

Week 4 — Integration

Refine playbook. Address day-30 wall.

05 · The capstone exercise

Spend 90 minutes building your playbook. Same structure as previous capstones.

06 · End of Module 04G

You've finished the regulatory affairs role path.

You can now:

  1. Use AI for regulatory work without compromising standards or compliance
  2. Apply the specific verification protocols that protect against AI failure modes in regulatory content
  3. Accelerate intelligence, drafting, and meeting prep work
  4. Document AI use defensibly

Path forward:

  • Advanced modules (05-10)
  • Cross-role learning (Clinical Operations 04D, Medical Writing 04H pair naturally)
  • Practice — fluency is in the use

End of Module 04G.